Istodax Disease Interactions

Romidepsin population pharmacokinetic analysis indicated that mild hepatic impairment had no significant influence on romidepsin pharmacokinetics. A dose reduction and close monitoring is recommended in patients with moderate and severe hepatic impairment.

Cases of fatal and serious infections, including pneumonia, sepsis, and viral reactivation, including Epstein Barr and hepatitis B viruses have been reported with the use of romidepsin. The risk of life threatening infections may be greater in patients with a history of prior treatment with monoclonal antibodies directed against lymphocyte antigens and in patients with disease involvement of the bone marrow. Monitor reactivation in patients with evidence of prior hepatitis B infection as recommended and consider antiviral prophylaxis as clinically indicated.

The use of romidepsin may cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia. It is recommended to monitor blood counts regularly during treatment, and if necessary to modify the dose of romidepsin according to clinical practices.

The use of romidepsin may cause changes in ECG. It is recommended to consider cardiovascular monitoring of ECG prior to starting therapy and periodically during treatment in patients with congenital long QT syndrome, history of significant cardiovascular disease, and in patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation. Confirm that potassium and magnesium levels are within normal range before administration of romidepsin. Care and close monitoring is recommended.

Romidepsin population pharmacokinetic analysis indicated that romidepsin pharmacokinetics were not affected by renal impairment. Care and close monitoring is recommended when prescribing this agent to patients with end-stage renal disease as the pharmacokinetics of romidepsin have not been studied in these patients.